BERT-Based Natural Language Processing of Drug Labeling Documents: A Case Study for Classifying Drug-Induced Liver Injury Risk [PDF]
Frontiers in Artificial Intelligence, 2021 Background & Aims: The United States Food and Drug Administration (FDA) regulates a broad range of consumer products, which account for about 25% of the United States market.
Yue Wu +4 more
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Information Extraction From FDA Drug Labeling to Enhance Product-Specific Guidance Assessment Using Natural Language Processing [PDF]
Frontiers in Research Metrics and Analytics, 2021 Towards the objectives of the UnitedStates Food and Drug Administration (FDA) generic drug science and research program, it is of vital importance in developing product-specific guidances (PSGs) with recommendations that can facilitate and guide generic ...
Yiwen Shi +5 more
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Drug labeling: The study of compliance of regulatory requirements for prescription drugs in India
Perspectives in Clinical Research, 2020 Objectives: The objective was to check the compliance of regulatory requirements of drug labeling in India according to guidelines given under the Drug and Cosmetic Rules (D & CRs) 1945, Section 96, 97; drug samples were collected from government drug ...
Suchi Shah, Anil Singh
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A digital twin approach for transforming prescription drug labeling [PDF]
Frontiers in PharmacologyDrug development entails extensive data collection by sponsors throughout research and development, followed by regulatory review, culminating in essential yet static prescription drug labeling.
Holly Kimko +2 more
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Study of serious adverse drug reactions using FDA-approved drug labeling and MedDRA [PDF]
BMC Bioinformatics, 2019 Background Adverse Drug Reactions (ADRs) are of great public health concern. FDA-approved drug labeling summarizes ADRs of a drug product mainly in three sections, i.e., Boxed Warning (BW), Warnings and Precautions (WP), and Adverse Reactions (AR), where
Leihong Wu +12 more
doaj +2 more sources
Drug labeling and exposure in neonates. [PDF]
JAMA Pediatr, 2014 Federal legislation has led to a notable increase in pediatric studies submitted to the Food and Drug Administration (FDA), resulting in new pediatric information in product labeling. However, approximately 50% of drug labels still have insufficient information on safety, efficacy, or dosing in children. Neonatal information in labeling is even scarcer
Laughon MM +7 more
europepmc +4 more sources
RxBERT: Enhancing drug labeling text mining and analysis with AI language modeling [PDF]
Experimental Biology and Medicine, 2023 Leihong Wu, Magnus Gray, Joshua Xu
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A Comparison of Safety Information in Drug Labeling at the Initial Approval of New Drugs Approved Both in Japan and the United States [PDF]
Therapeutic Innovation and Regulatory Science, 2022 Yuko Hoshino, Narukawa Mamoru
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Baclofen approval in france: A balance between two conceptions of medicine
European Psychiatry, 2021 In October 2018, France became the first country to officially approve baclofen for alcohol use disorder (AUD), even if the French Drug Agency (ANSM) officially stated that the efficacy of baclofen in AUD could be not established at this stage, in the ...
B. Rolland
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Neural text generation in regulatory medical writing
Frontiers in Pharmacology, 2023 Background: A steep increase in new drug applications has increased the overhead of writing technical documents such as medication guides. Natural language processing can contribute to reducing this burden.Objective: To generate medication guides from ...
Claudia Meyer +5 more
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